Syneos Health and Tufts CSDD study finds no superior CRO model
Syneos Health has published findings from a benchmarking study conducted with the Tufts Center for the Study of Drug Development that challenges one of the drug industry's most enduring assumptions: that picking the right sourcing model is the primary lever for clinical trial performance.
The study, which covered 13 sponsor companies, 81 development programmes and 133 clinical trials, found that no single model, whether in-house, full-service CRO or functional service provider (FSP), consistently outperformed the others across measures of timeline, quality and execution. The conclusion, instead, is that how a model is designed and coordinated matters more than which model is chosen.
What the data shows
The research identified a notable pattern around vendor complexity. Sponsors using a greater number of service providers tended to experience longer timelines from protocol approval to database lock, higher dropout rates in certain contexts and a higher incidence of protocol amendments and quality events. The study framing is careful to note this is not simply a case of "fewer partners equals better results"; rather, it points to the consequences of inadequate coordination across a fragmented ecosystem.
Kenneth Getz, executive director and research professor at Tufts CSDD, said the sector has long operated on strongly held views about which sourcing arrangements work best, while lacking objective comparative data. "This study gives sponsors a more rigorous, evidence-based foundation for considering how development work should be structured around portfolio requirements and the unique scientific and executional demands of clinical trial activity," he said.
Michael Brooks, chief operating officer at Syneos Health, framed the findings as a prompt for sponsors to treat operating model design as a strategic capability in its own right, rather than a procurement decision. The release points to precision medicine advances, compressed timelines, evolving regulatory expectations and AI-enabled trial technologies as forces reshaping how programmes are run.
Market context
The CRO sector has faced structural pressure for several years, with sponsors oscillating between consolidated full-service relationships and more modular FSP arrangements in search of cost and speed advantages. The debate has intensified as trial complexity has grown: larger protocol amendments, adaptive designs and decentralised trial components all add coordination overhead, regardless of sourcing strategy.
Syneos Health is itself a major participant in this market, which is worth noting as context for the study's commissioning. Tufts CSDD operates as an independent academic centre, providing a degree of methodological distance, though the partnership with a commercial CRO is standard practice in industry-funded research and editors may wish to keep that framing visible in coverage.
The findings carry implications beyond individual trial decisions. If operating model design is the key performance variable, sponsors with fragmented legacy vendor ecosystems and weak governance frameworks face a structural disadvantage that cannot be resolved simply by switching CRO. For the sector, the study adds empirical weight to a direction many large biopharmaceutical companies are already moving: building dedicated clinical operations functions with clearer accountability structures, rather than defaulting to outsourcing as a one-size solution.
Syneos Health said sponsors can engage with the company directly to discuss adaptive operating approaches. The full benchmarking study is available for download, and the firm is presenting findings at the DPHARM industry conference.